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Gs

FDA UDI

Class II (US FDA UDI)

by Bio-Rad Laboratories

Identity

Trade Name
GS FDA UDI
Generic Name
Hepatitis B virus surface antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal) GS HBsAg EIA 3.0 960 Tests FDA UDI
Model / Reference
32592 FDA UDI
Description
Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal) GS HBsAg EIA 3.0 960 Tests FDA UDI

Identifiers

Catalog Number
32592 FDA UDI
Primary DI / UDI-DI
00847865001830 FDA UDI
FDA Product Code
LOM FDA UDI
GMDN Term
Hepatitis B virus surface antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3172 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Hepatitis B virus surface antigen IVD, kit, enzyme immunoassay (EIA)

Gs by Bio-Rad Laboratories — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hepatitis B virus surface antigen IVD, kit, enzyme immunoassay (EIA).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bio-Rad Laboratories

Sources (1)

  • FDA UDI 545b3c6f-f811-4227-89cc-ef65f1634e0f 37 fields · synced May 29, 2026